Portable minimally invasive hemostasis device for nasal passage

Abstract

The present invention discloses a portable minimally invasive hemostasis device for nasal passage, comprising a positioning handle, a surgical instrument control unit, a driving handle, a nasal mirror and a bedside device; wherein the positioning handle comprises a limiting device, a front handle and a positioning device; the surgical instrument control unit comprises at least a cutter head, a continuum, a connecting rod, internal organs and a base; the surgical instrument control unit is installed on the front handle of the positioning handle through a connecting rod, and is parallel to the limiting device, and the connecting rod can move linearly relative to the positioning handle; the driving handle is fixedly connected to the surgical instrument control unit, so that the driving handle can move parallel to the positioning handle without deflection; the nasal mirror can be inserted into the limiting device of the positioning handle as needed. The present invention can be operated by one person, has a large working space, and the cutter head can be replaced according to the surgical needs before the operation. During the operation, the gear position, plasma charging and discharging and other operations can be adjusted to achieve functions such as low-temperature ablation, cutting, hemostasis, and coagulation. The minimally invasive surgical process is safe and reliable.

Description

Technical Field

[0001] The invention relates to a minimally invasive hemostasis medical device, in particular to a portable minimally invasive transnasal hemostasis device suitable for otolaryngology. Background Art

[0002] Nosebleed is one of the most common emergencies in the otolaryngology department. The main treatment measures that can be taken at the bleeding site are nasal packing and nasal hemostasis equipment. Hemostasis using electrocoagulation, radiofrequency and other means is minimally invasive and has better surgical effects. Among them, plasma technology is used to excite the medium (Nacl) with ultra-low frequency 100KHz electrical energy to produce plasma, so that the hemostasis process is completed within 40℃-70℃, with good minimally invasive effects and low secondary damage. At present, conventional plasma and other hemostatic instruments are usually used by physicians holding a nasal mirror, placing the plasma blade at the bleeding site under the observation of a camera, and performing the operation with an aspirator during the operation. The otolaryngology area has a narrow space, complex components, and many important anatomical structures. It is the basis of functions such as breathing, chewing, and swallowing. Traditional nasal endoscopic surgery is limited by factors such as space and field of view. It often requires one doctor to hold the nasal endoscope and another doctor to operate the surgical instrument to perform the surgery in conjunction with the suction function during the operation. This surgical method is labor-intensive to a certain extent and inconvenient to operate. The end of the handheld medical instrument operated by the doctor often cannot move flexibly, which also increases the difficulty of the doctor's nasal endoscopic surgery. It cannot be used quickly, conveniently and accurately for patients with severe nasal bleeding. In recent years, robotic surgery has gradually been favored by surgeons for its advantages such as precision and minimally invasiveness. Using surgical robots, surgical instruments and energy instruments can be applied to the operation under the guidance of the endoscope through the control of the physician to achieve precise hemostasis. However, the robot system is usually complex in configuration, involving subsystems such as the doctor's console and bedside robotic arm. It requires the cooperation of multiple operators to perform the operation by controlling the main hand to remotely operate the bedside robotic arm, which is not suitable for the fast and convenient requirements of intranasal hemostasis.

[0003] Therefore, it is very important to develop a portable transnasal minimally invasive hemostasis device, which makes full use of the surgical style of hemostasis under nasal endoscope, only needs one person to operate it handheld, and is equipped with a high-definition nasal endoscope to provide surgical field of view. The end of the surgical instrument can be bent at a large angle for positioning and posture, which has a wide surgical range and good use effect. Summary of the invention

[0004] The purpose of the present invention is to provide a portable minimally invasive transnasal hemostasis device to solve the problem that the prior art cannot realize single-person operation of the equipment for ENT surgery, but requires one person to hold the nasal endoscope while the other person operates the surgical equipment to perform the surgery, which is labor-intensive and inconvenient to operate. In addition, the end of the handheld medical instrument operated by the doctor often cannot move flexibly, which greatly increases the difficulty of the doctor performing nasal endoscopic surgery.

[0005] The present invention proposes a portable minimally invasive transnasal hemostasis device that can be operated by one person and can stably and accurately perform hemostasis, suction, excision and other surgical operations deep inside the ear, nose and throat. The device is easy to operate and has high flexibility. The appropriate blade can be selected according to different diseases, different parts and different surgical requirements to achieve simple and quick implementation of ear, nose and throat surgical operations.

[0006] A portable minimally invasive hemostasis device for transnasal use, comprising a positioning handle, a surgical instrument control unit, a driving handle, a nasal mirror and bedside equipment; wherein the positioning handle comprises a limit device, a front handle and a positioning device; the surgical instrument control unit comprises at least a cutter head, a continuum, a connecting rod, internal organs and a base;

[0007] The surgical instrument control unit is installed on the front handle of the positioning handle through a connecting rod and is parallel to the limiting device. The connecting rod can move linearly relative to the positioning handle; the driving handle is fixedly connected to the surgical instrument control unit so that the driving handle can move parallel to the positioning handle without deflection; the nose mirror can be inserted into the limiting device of the positioning handle as needed.

[0008] The continuum of the surgical instrument control unit is installed at the rear end of the connecting rod, the connecting rod is fixedly connected to the base, and the blade is installed at the end of the surgical instrument control unit. The continuum and the connecting rod are hollow inside, and the internal organs pass through the middle of the continuum and the connecting rod to connect to the base, and are further connected to the bedside equipment.

[0009] The surgical instrument control unit has more than three degrees of freedom, including yaw motion, pitch motion, and forward and backward motion of the following drive handle, so as to position and determine the posture of the cutting head.

[0010] The positioning handle can provide positioning and limiting for the driving handle, so that the driving handle can move forward, backward or rotate around the central axis of the limiting device relative to the positioning handle within a set range.

[0011] Furthermore, the limiting device 11 of the positioning handle 1 is composed of a nasal mirror sleeve 111 and a spring 112, and the front handle 12 is composed of a front handle base 121 and a butterfly bolt 126. The front handle is provided with a first hole 122 for cooperating with the surgical instrument control unit 2, and a second hole 123 for assembling the nasal mirror sleeve 111; the distance between the first hole and the second hole is less than 1.5 mm; a groove 124 with a width of less than 1 mm is provided in the middle of the upper end of the front handle base 121, extending from the top plane to the second hole 123; the front handle is further provided with a third hole 127, a butterfly bolt 126, and a third hole 128. The butterfly bolt is assembled in the third hole; the positioning device 13 is composed of a positioning button 131 and a positioning spring 132. The positioning device 13 is installed on the base 29. A row of positioning holes 114 are opened on the nose mirror sleeve 111. The positioning button 131 is designed as a hook-shaped structure. When the positioning button 131 is pressed, the positioning spring 132 is compressed, and the positioning button 131 leaves the positioning hole 114, and the driving handle 3 can move forward and backward relative to the positioning handle 1; when the positioning button 131 is released, the positioning spring 132 is extended, and the positioning button 131 is inserted into the positioning hole 114, which can fix the relative position of the driving handle 3 and the positioning handle 1. A reset spring 112 is installed between the base 29 and the front handle base 121. When the positioning button 131 is pressed, the spring 112 can assist the driving handle to retreat. At the same time, there is a limit ring 113 on the nose mirror sleeve 111 to limit the distance of the driving handle 3 moving backward.

[0012] Furthermore, the surgical instrument control unit further includes a thin tube, a driving unit, a pulley, a support rod, and a steel wire; the internal organs 28 include a plasma power cable 281 and a suction device 282, which are installed inside the continuum 22 and the connecting rod 23, and are connected to the bedside device 5 through the rear end interface 291 of the base 29. The continuum 22 is driven by a steel wire, which passes through the continuum 22 and the connecting rod 23. When passing through the connecting rod 23, a thin tube 24 with a diameter slightly larger than the diameter of the steel wire is installed, which is used to guide the steel wire inside the connecting rod 23. After passing through the connecting rod 23, the steel wire is connected to the driving unit 25 through the pulley 26, and the pulley 26 is installed on the support rod 27.

[0013] The support rod 27 is installed on the base 29 at a certain angle a relative to the line connecting the output shafts of the two drive units 25, so that the steel wire from the capillary 24 is still perpendicular to the central axis of the support rod 27 (angle b=90°) after passing around the pulley 26 (the stretching direction of the steel wire), thereby reducing the friction between the steel wire and the pulley 26. The size of a is a=arctan(L / H), L*2 is the distance from the line connecting the output shafts of the two drive units 25, and H is the distance from the capillary to the line connecting the output shafts of the two drive units 25.

[0014] The driving unit 25 is composed of a motor 251, a driving connecting rod 252, a wire pre-tightening device 254 and a connecting disc 256, and can drive the continuum 22 to bend more than 200° in four directions. The motor 251 is fixedly connected to the connecting disc 256. The connecting disc is fixedly connected to the driving connecting rod 252 by bolts 253. The steel wire pre-tightening device 254 is used for pre-tightening the steel wire, specifically a cylindrical structure, divided into an upper cylinder 2541 and a lower cylinder 2542. A fine groove 25411 is opened on the end face of the upper cylinder, and the fine groove passes through the center of the circle. The fine groove penetrates to the connecting plane of the upper and lower cylinders on one side of the upper cylinder, and is deep to a distance c from the connecting plane on the other side, so that the upper cylinder has a certain bending elasticity in the direction of the fine groove; a threaded hole is opened on the upper cylinder perpendicular to the fine groove for installing a pre-tightening bolt 255. The steel wire pre-tightening device is axially perforated and coaxially connected to the output shaft of the driving connecting rod 252. Tightening the pre-tightening bolt 255 can fix the steel wire pre-tightening device 254 and the driving connecting rod 252. When the pre-tightening bolt 255 is not tightened, the wire pre-tightening device 254 can rotate relative to the driving connecting rod 252. The wire pre-tightening device 254 and the driving connecting rod 252 each have a wire pre-tightening device hole 25421 and a driving connecting rod hole 2521 for fixing the wire. During the instrument production process, the motor 251 is first fixed to the rear handle 32 by the bolt 29, the connecting disc 256 is connected and fixed to the motor 251 by bolts and splines, and then the driving connecting rod 252 is fixed to the connecting disc 256 by the motor connecting bolt 253. One end of two steel wires symmetrical about the center line of the connecting rod 23 are fixed at the end of the continuum 22. After the other end of one of the steel wires passes through the small hole 25421 of the steel wire pre-tightening device and the other end of the other steel wire passes through the small hole 2521 of the driving connecting rod, a small capillary (a steel tube with an outer diameter slightly larger than the diameter of the small hole 25421 of the steel wire pre-tightening device and a length less than 10 mm) is used to pinch the steel wires to prevent the steel wires from escaping from the steel wire pre-tightening device 254 and the driving connecting rod 252; during the pre-tightening process, the motor 251 is rotated to wrap the steel wire passing through the small hole 2521 of the driving connecting rod around the threaded groove of the driving connecting rod 252 and tighten it, and then fix it in place; the steel wire pre-tightening device 254 is manually installed on the driving connecting rod 252, and the other steel wire is wrapped around the threaded groove of the steel wire pre-tightening device 254 by rotating the steel wire pre-tightening device 254, and finally the pre-tightening bolt 255 is tightened to fix the steel wires.

[0015] Furthermore, the continuum 22 is composed of more than 2 joints, and the optimal number is 10; the axes of rotation of adjacent joints are perpendicular to each other. The joints are assembled together by steel wires. Each joint can rotate more than 40 degrees on one side relative to the adjacent joint, so the continuum 22 can rotate more than 200 degrees in all four directions, and the cutter head 21 can be delivered to the surgical area.

[0016] One design form of the joint is that the joint is composed of two joint connecting rods 221 nested and connected. The joint connecting rod is a cylindrical structure with openings at both ends, with an outer diameter less than 5mm and an inner hole diameter greater than 3mm, which is used to place internal organs 28. Four wire holes 223 are evenly distributed in the outer wall of the joint connecting rod for inserting steel wires, two of which are symmetrical with respect to the central axis and are used to control the pitch motion of the continuum 22, and the other two steel wires symmetrical with respect to the central axis are responsible for the deflection motion. One end opening of the joint connecting rod 221 is provided with two arc grooves 224, and the other end opening is provided with two raised shafts 222. The axis connecting line of the two arc grooves 224 on the joint connecting rod 221 and the axis connecting line of the two raised shafts 222 are perpendicular to each other at 90 degrees. The plane cutting angle α on both sides of the arc groove 224 and the raised shaft 222 is greater than 20 degrees, and the single joint design rotation angle is greater than 40 degrees. The outer end surfaces of the arc groove 224 and the protruding shaft 222 are small-angle γ conical surfaces, and the direction of the cone line points to the inside of the joint to ensure that the two joints are not separated.

[0017] Another design form of the joint is that the joint consists of two half-connecting rods 225 and a connecting part 227, and the half-connecting rod is a cylindrical structure with openings at both ends; the outer diameter of the half-connecting rod 225 is less than 5 mm, and the inner hole diameter is greater than 3 mm, which is used to place internal organs 28. There are 4 wire holes 228 evenly distributed on the outer wall of the half-connecting rod for inserting steel wires, two steel wires symmetrically installed relative to the central axis are used to control the pitch movement of the continuum 22, and the other two steel wires symmetrically installed relative to the central axis are responsible for the deflection movement.

[0018] One end opening of the half connecting rod 225 is provided with two protruding shafts 226, and the other end opening is provided with four groups of evenly distributed protruding parts 2211 and grooves 2212, which are used to connect two adjacent half connecting rods 225. The protruding part 2211 of one half connecting rod can be placed in the groove 2212 of the other half connecting rod. The connecting part 227 is provided with arc grooves 229 on the upper and lower sides, which cooperate with the protruding shaft 226 of the half connecting rod; the arc groove 229 is provided with a baffle 2210 extending in the reverse direction along the axial direction of the joint, which is used to prevent the connecting part 227 from falling; that is, the baffle 2210 extending from the arc groove 229 on the upper part of the connecting part is located at the lower part of the connecting part, and the baffle 2210 extending from the arc groove on the lower part of the connecting part is located at the upper part of the connecting part. The plane cutting angle β on both sides of the protruding shaft 226 is greater than 20 degrees, and the single joint design rotation angle is greater than 40 degrees.

[0019] The driving handle 3 includes a rear handle 32, a control button assembly 33, a direction button 34 and a fixing plate 35. The rear handle 32 is fixedly connected to the base 29 via a bolt 31, the motor 251 of the surgical instrument control unit is fixedly connected to the rear handle 32 via a bolt 39, and the control button assembly 33 and the direction button 34 are installed at a fixed position of the rear handle 32.

[0020] The control button assembly 33 can be used to select the surgical mode, adjust the power gear, reset the surgical instrument control unit 2, and control the charging and discharging of the cutter head 21. The direction button 34 is used to control the rotation of the motor 251, pull the steel wire, drive the continuum 22 to bend in the corresponding direction, and send the cutter head 21 to the designated surgical area. The fixing plate 35 is fixedly connected to the rear handle 32, and the fixing plate 35 is fixedly connected to the base 29 to provide support for the base 29. A bearing 37 is installed on the fixing plate 35, which is used to cooperate with the steel wire pre-tightening device 254 to stabilize the driving connecting rod 252.

[0021] A wire-driven, single-operated minimally invasive hemostasis medical device. During the surgical operation, the device must first be turned on, the surgical mode must be selected, and parameters such as the power gear must be adjusted. Then, the surgical area must be found through the nasal endoscope, the positioning handle must be fixed, the driving handle must move relative to the positioning handle, and then the direction button must be pressed to send the blade to the surgical area. Finally, the charge and discharge control button must be pressed to control the blade to perform the surgical operation. After the operation, the motor of the driving part must be reset to zero, the surgical execution part must be adjusted back to the initial state, and then the device must be turned off, the instrument must be removed from the human body, and the operation must be completed.

[0022] The control method of the portable minimally invasive hemostasis device of the present invention is as follows: Fig.22a , b as shown:

[0023] The relationship between the bending angle θ, curvature k, length l of the central axis of the continuum, and the curvature radius R is known as:

[0024]

[0025] Get the x of direction button 34 i Axis and y i Axis input data;

[0026] Depend on Fig.22a The geometric relationship can be obtained, the continuum joint end position x = k x x i and y = k y y i , k x and k y is the geometric scaling factor, then the representation in the Cartesian coordinate system is:

[0027]

[0028]

[0029] After transformation, we can get:

[0030]

[0031]

[0032] Input the x-axis and y-axis data into the above equations (4) and (5), and use the iterative method to solve the nonlinear equations to calculate θ and φ.

[0033] Depend on Figure 22b The geometric relationship is that when the rotation angle of the continuum 22 is φ, the curvature radius R of the central axis of the continuum and the curvature radius R of each driving wire are i The relationship is as follows:

[0034] R i =R-rcosα i (6)

[0035] Where r is the distance between the steel wire and the central axis of the continuum;

[0036] Multiply both sides of equation (6) above by θ and assume that l i =R i θ, we can get:

[0037] l i =l-rθcosα i (7)

[0038] l i It represents the length of the i-th driving wire after the continuum is bent at an angle of θ. i represents the change of the i-th driving wire, then l i = l-Δl i The curvature of the continuum is represented by k, so:

[0039] Δl i = rθcosα i (8)

[0040] The driving wire uses a closed-loop drive method, and the following relationship exists:

[0041] Δl 1 =-Δl 3 (9)

[0042] Δl 2 =-Δl 4 (10)

[0043] According to formula (8) and α i The value of can be obtained:

[0044]

[0045]

[0046] Substituting the calculated θ and φ into formula (12), we can calculate Δl 1 and Δl 2 , the diameter of the driving connecting rod is known to be d, then the motor rotation position is:

[0047]

[0048]

[0049] The portable minimally invasive transnasal hemostasis device designed by the present invention can realize single-person operation for narrow parts such as the ear, nose and throat. The image of the nasal mirror is stable during use, the surgical instrument has three degrees of freedom, the end of the surgical instrument can be bent up to 210°, and the surgical instrument has a large working space, which meets the needs of ear, nose and throat surgery. The blade can be replaced according to the surgical needs before the operation, and the gear position, plasma charging and discharging and other operations can be adjusted during the operation to achieve low-temperature ablation, cutting, hemostasis, coagulation and other functions. The minimally invasive surgical process is safe and reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Figure 1 The overall structure diagram of the portable minimally invasive hemostasis device of the present invention is shown as follows

[0051] Figure 2 Shown Figure 1 Exploded diagram of local structure

[0052] Figure 3a-3d Schematic diagram of the bending angle limit of the continuum in the surgical instrument control unit of the device of the present invention and the forward and backward movement of the driving handle

[0053] Figure 4 The figure shows the structure schematic diagram of the positioning handle of the device of the present invention.

[0054] Figure 5 Shown Figure 4 Exploded view

[0055] Figure 6 The figure shows the overall structure of the surgical instrument control unit of the device of the present invention.

[0056] Figure 7 Shown Figure 6 Exploded view

[0057] Figure 8 The figure shows the support rod installation angle diagram of Figure 7

[0058] Fig. 9 Shown Figure 7 Partial cross-sectional view of the middle connecting rod and internal organs

[0059] Fig.10 Shown Figure 7 Schematic diagram of the overall structure of the middle drive unit

[0060] Fig.11 Shown Fig.10 Schematic diagram of the connection between the motor and the connecting disc

[0061] Fig.12a , b shows Fig.10 Schematic diagram of the structure of the steel wire pre-tightening device and the driving connecting rod

[0062] Fig.13 Shown Figure 7 One of the joint structures of the continuum

[0063] Fig.14 Shown Fig.13 Exploded view

[0064] Fig.15 Schematic diagram of the first type of joint unilateral plane cutting angle

[0065] Fig.16 Schematic diagram of the first type of joint cone angle

[0066] Fig.17 Shown Figure 7 The joint structure diagram of the middle continuum (part 2)

[0067] Fig.18 Shown Fig.17 Exploded view

[0068] Fig.19 Schematic diagram of the second type of joint unilateral plane cutting angle

[0069] Fig. 20 The figure shows the overall structure of the driving handle of the device of the present invention.

[0070] Fig.21 Shown Fig.21 Exploded view

[0071] Fig.22a , b shows the continuum control model diagram

[0072] The specific numbers in the figure are as follows:

[0073] 1. Positioning handle 2. Surgical instrument control unit 3. Driving handle 4. Nose mirror 5. Bedside equipment

[0074] 11. Limiting device 12. Front handle 13. Positioning device

[0075] 111, nose mirror sleeve 112, spring 113, limit ring 114, positioning hole

[0076] 121, front handle base 122, first hole 123, second hole 124, groove

[0077] 125, butterfly nut 126, butterfly bolt 127, third hole

[0078] 131. Positioning button 132. Positioning spring

[0079] 21. plasma cutter head 22. continuum 23. connecting rod 24. capillary tube 25. drive unit

[0080] 26, pulley 27, support rod 28, internal organs 29, base 291, rear end interface

[0081] 221, joint connecting rod 222, raised shaft 223, wire-feeding hole 224, arc groove

[0082] 225, half connecting rod 226, raised shaft 227, connecting piece 228, wire feeding hole

[0083] 229, arc groove 2210, baffle 2211, raised portion 2212, groove

[0084] 251, motor 252, driving connecting rod 2521, driving connecting rod small hole 253, motor connecting bolt

[0085] 254, wire pre-tightening device 2541, upper cylinder 25411, fine groove

[0086] 2542, lower cylinder 25421, small hole of wire pre-tightening device 255, pre-tightening bolt

[0087] 256, connecting disc 281, plasma power cable 282, suction device 31, base bolt

[0088] 32. Rear handle 33. Control button 34. Direction button 35. Fixing plate

[0089] 36. Fixing plate bolts 37. Bearing 38. Fixing plate base bolts 39. Motor fixing bolts DETAILED DESCRIPTION

[0090] The present invention is further described below in conjunction with the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it, but the embodiments are not intended to limit the present invention.

[0091] The present invention is a portable minimally invasive hemostatic device for nasal passage. Figure 1 , Figure 2As shown, it includes a positioning handle 1, a surgical instrument control unit 2, a driving handle 3, a nose mirror 4 and a bedside device 5. Among them, the positioning handle includes a limit device 11, a front handle 12 and a positioning device 13; the surgical instrument control unit includes at least a plasma cutter head 21, a continuum 22, a connecting rod 23, an internal organ 28 and a base 29;

[0092] The connecting rod 23 of the surgical instrument control unit 2 is installed in the front handle of the positioning handle 1 and is located below and parallel to the nasal endoscope sleeve 111. The connecting rod 23 can move linearly relative to the positioning handle 1. The driving handle 3 and the surgical instrument control unit 2 are fixedly connected by bolts, so that the driving handle 3 can move parallel to the positioning handle 1 without deflection. At the same time, the distance between the connecting rod 23 and the nasal endoscope sleeve 111 is less than 1.5mm, so that the nasal endoscope 4 and the end continuum 22 of the surgical instrument control unit 2 can smoothly enter the narrow parts of the human body such as the ear, nose and throat for surgery. The plasma cutter head 21 is installed at the end of the surgical instrument control unit 2, and the plasma cable 281 and the suction tube 282 pass through the continuum 22 of the surgical instrument control unit 2 and the connecting rod 23 ( Fig. 9 ), the end is fixed to one end of the connecting rod 23, and the other end of the connecting rod 23 is fixedly connected to the base 29 and connected to the bedside device 5. Before the operation, the nose mirror 4 is inserted into the nose mirror sleeve 111 of the positioning handle 1.

[0093] The surgical instrument control unit 2 can perform yaw motion, pitch motion, and forward and backward motion following the driving handle 3, and has more than three degrees of freedom, so as to position and determine the posture of the plasma cutter head 21. Figure 3a-3d )

[0094] like Figure 4 , 5As shown, the positioning handle 1 includes a limiting device 11, a front handle 12 and a positioning device 13. The limiting device 11 is composed of a nose mirror sleeve 111 and a spring 112, and the front handle 12 is composed of a front handle base 121 and a butterfly bolt 126. The front handle 12 is provided with a first hole 122 for cooperating with the surgical instrument control unit 2, and a second hole 123 for assembling the nasal mirror sleeve 111, and the distance between the first hole and the second hole is less than 1.5 mm; a groove 124 is provided in the middle of the upper end of the front handle base 121, extending from the top plane to the second hole 123 and with a width less than 1 mm; the front handle is further provided with a third hole 127, a butterfly bolt 126 is inserted from the left side of the third hole 127, and a butterfly nut 125 is installed on the right side of the third hole 127; loosen the butterfly bolt 126, the nasal mirror sleeve 111 can move forward and backward relative to the front handle base 121, tighten the butterfly bolt 126, the nasal mirror sleeve 111 is pressed by the front handle base 121, and the nasal mirror sleeve 111 is fixedly connected to the front handle base 121. The positioning device 13 is composed of a positioning button 131 and a positioning spring 132. The positioning device 13 is installed on the base 29. A row of positioning holes 114 are opened on the nose mirror sleeve 111. The positioning button 131 is designed as a hook-shaped structure. When the positioning button 131 is pressed, the positioning spring 132 is compressed, and the positioning button 131 leaves the positioning hole 114, and the driving handle 3 can move forward and backward relative to the positioning handle 1; when the positioning button 131 is released, the positioning spring 132 is extended, and the positioning button 131 is inserted into the positioning hole 114, which can fix the relative position of the driving handle 3 and the positioning handle 1. A reset spring 112 is installed between the base 29 and the front handle base 121. When the positioning button 131 is pressed, the spring 112 can assist the driving handle to retreat. At the same time, there is a limit ring 113 on the nose mirror sleeve 111, which can limit the distance of the base 29 moving backward, thereby limiting the distance of the driving handle 3 moving backward.

[0095] like Figure 6 , 7 As shown, the surgical instrument control unit 2 includes a plasma cutter head 21, a continuous body 22, a connecting rod 23, a capillary 24, a driving unit 25, a pulley 26, a support rod 27, an internal organ 28, a base 29 and a steel wire. The plasma cutter head 21 can be selected before surgery. According to the surgical requirements, a plasma cutter head 21 with different diameters, angles and energy meters is selected and installed at the end of the continuous body 22. The continuous body 22 is installed at the rear end of the connecting rod 23, and the connecting rod 23 is fixedly connected to the base 29. The internal organ 28 includes a plasma power cable 281 and a suction device 282 (such as Fig. 9 ), installed inside the continuum 22 and the connecting rod 23, and connected to the bedside device 5 through the rear end interface 291 on the base 29. The continuum 22 is driven by a steel wire, which passes through the continuum 22 and the connecting rod 23. When passing through the connecting rod 23, a thin tube 24 with a diameter slightly larger than the diameter of the steel wire is installed to guide the steel wire inside the connecting rod 23 (such as Fig. 9), the steel wire passes through the connecting rod 23 and is connected to the driving unit 25 through the pulley 26, and the pulley 26 is installed on the support rod 27.

[0096] like Figure 8 As shown, the support rod 27 is installed on the base 29 at a certain angle a relative to the line connecting the output shafts of the two drive units 25, so that the steel wire from the capillary 24 is still perpendicular to the central axis of the support rod 27 (angle b = 90°) after passing around the pulley 26 (the stretching direction of the steel wire), thereby reducing the friction between the steel wire and the pulley 26. The size of a is a = arctan (L / H), L*2 is the distance from the line connecting the output shafts of the two drive units 25, and H is the distance from the capillary to the line connecting the output shafts of the two drive units 25.

[0097] like Fig.10 As shown, the driving unit 25 is composed of a motor 251, a driving connecting rod 252, a wire pre-tightening device 254 and a connecting disc 256, which can drive the continuum 22 to bend more than 200 degrees in four directions. The connecting disc 256 is fixed to the motor 251 by bolts and splines (such as Fig.11 ). The connecting disc is fixedly connected to the driving connecting rod 252 by bolts 253. Fig.12aAs shown in , b, the steel wire pre-tightening device 254 is used to pre-tighten the steel wire, specifically a cylindrical structure, divided into an upper cylinder 2541 and a lower cylinder 2542, a fine groove 25411 is opened on the end face of the upper cylinder, and the fine groove passes through the center of the circle, and the fine groove penetrates to the connecting plane of the upper and lower cylinders on one side of the upper cylinder, and is deep to a distance c from the connecting plane on the other side, so that the upper cylinder has a certain elasticity in the direction of the fine groove; a threaded hole is opened on the upper cylinder perpendicular to the fine groove for installing a pre-tightening bolt 255, the steel wire pre-tightening device is axially perforated and coaxially connected to the output shaft of the driving connecting rod 252, and tightening the pre-tightening bolt 255 can fix the steel wire pre-tightening device 254 and the driving connecting rod 252. When the pre-tightening bolt 255 is not tightened, the wire pre-tightening device 254 can rotate relative to the driving connecting rod 252. The wire pre-tightening device 254 and the driving connecting rod 252 each have a wire pre-tightening device hole 25421 and a driving connecting rod hole 2521 for fixing the wire. During the instrument production process, the motor 251 is first fixed to the rear handle 32 by the bolt 29, the connecting disc 256 is fixedly connected to the motor 251, and then the driving connecting rod 252 and the connecting disc 256 are fixed by the motor connecting bolt 253. One end of two steel wires symmetrical about the center line of the connecting rod 23 is fixed to the end of the continuum 22. After the other end of one of the steel wires passes through the small hole 25421 of the steel wire pre-tightening device and the other end of the other steel wire passes through the small hole 2521 of the driving connecting rod, a small capillary (a steel pipe with an outer diameter slightly larger than the diameter of the small hole 25421 of the steel wire pre-tightening device and a length less than 10 mm) is used to pinch the steel wires to prevent the steel wires from escaping from the steel wire pre-tightening device 254 and the driving connecting rod 252; during the pre-tightening process, the motor 251 is rotated to wind the steel wires around the threaded groove of the driving connecting rod 252 and tighten them, and then fix them in place; the steel wire pre-tightening device 254 equipped with another steel wire is manually installed on the driving connecting rod 252, and then the steel wire pre-tightening device is rotated to make the steel wire wind around the threaded groove of the steel wire pre-tightening device 254, and finally the pre-tightening bolt 255 is tightened to fix the steel wires.

[0098] Furthermore, the continuum 22 is composed of more than 2 joints, and the optimal number is 10; the axes of rotation of adjacent joints are perpendicular to each other. The joints are assembled together by steel wires. Each joint can rotate more than 40 degrees on one side relative to the adjacent joint, so the continuum 22 can rotate more than 200 degrees in all four directions, and the cutter head 21 can be delivered to the surgical area.

[0099] like Fig.13 , 14As shown, one design form of the joint is that the joint is composed of two joint connecting rods 221 that are nested and connected. The joint connecting rod is a cylindrical structure with openings at both ends, with an outer diameter less than 5mm and an inner hole diameter greater than 3mm, which is used to place internal organs 28. Four wire holes 223 are evenly distributed on the outer wall of the joint connecting rod for inserting steel wires, two of which are symmetrical with respect to the central axis and are used to control the pitch motion of the continuum 22, and the other two steel wires that are symmetrical with respect to the central axis are responsible for the deflection motion. One end of the joint connecting rod 221 is opened and provided with two arc grooves 224, and the other end is opened and provided with two raised shafts 222. The axis connecting line of the two arc grooves 224 on the joint connecting rod 221 and the axis connecting line of the two raised shafts 222 are perpendicular to each other at 90 degrees. The plane cutting angle α on both sides of the arc groove 224 and the raised shaft 222 is greater than 20 degrees (such as Fig.15 The single joint design has a rotation angle greater than 40 degrees. The outer end surfaces of the arc groove 224 and the protruding shaft 222 are small angle γ conical surfaces (such as Fig.16 The direction of the cone line points to the inside of the joint to ensure that the two joints do not separate.

[0100] like Fig.17 , 18 As shown, another design form of the joint is that the joint consists of two half-connecting rods 225 and a connecting part 227, and the half-connecting rod is a cylindrical structure with openings at both ends; the outer diameter of the half-connecting rod 225 is less than 5 mm, and the inner hole diameter is greater than 3 mm, which is used to place internal organs 28, and four wire holes 228 are evenly distributed on the outer wall of the half-connecting rod for inserting steel wires. Two steel wires symmetrically installed relative to the central axis are used to control the pitch movement of the continuum 22, and the other two steel wires symmetrically installed relative to the central axis are responsible for the deflection movement.

[0101] One end opening of the half-connecting rod 225 is provided with two raised shafts 226, and the other end opening is provided with four groups of evenly distributed raised portions 2211 and grooves 2212, which are used for connecting two adjacent half-connecting rods 225. The raised portion 2211 of one half-connecting rod can be placed in the groove 2212 of the other half-connecting rod. The connecting component 227 is provided with arc grooves 229 on the upper and lower sides, which cooperate with the raised shafts 226 of the half-connecting rod; the arc grooves 229 are provided with baffles 2210 extending in the reverse direction of the joint axis to prevent the connecting component 227 from falling; that is, the baffle 2210 extending from the arc groove 229 on the upper part of the connecting component is located at the lower part of the connecting component, and the baffle 2210 extending from the arc groove on the lower part of the connecting component is located at the upper part of the connecting component. The plane cutting angles β on both sides of the raised shaft 226 are both greater than 20 degrees (such as Fig.19 The single joint design has a rotation angle greater than 40 degrees.

[0102] like Fig. 20 , 21As shown, the driving handle 3 includes a rear handle 32, a control button assembly 33, a direction button 34 and a fixing plate 35. The rear handle 32 is fixedly connected to the base 29 via a bolt 31, the motor 251 of the surgical instrument control unit is fixedly connected to the rear handle 32 via a bolt 39, and the control button assembly 33 and the direction button 34 are installed at a fixed position of the rear handle 32.

[0103] The control button assembly 33 can be used to select the surgical mode, adjust the power gear, reset the surgical instrument control unit 2, and control the charging and discharging of the cutter head 21. The direction button 34 is used to control the rotation of the motor 251, pull the steel wire, drive the continuum 22 to bend in the corresponding direction, and send the cutter head 21 to the designated surgical area. The fixing plate 35 is fixedly connected to the rear handle 32, and the fixing plate 35 is fixedly connected to the base 29 to provide support for the base 29. A bearing 37 is installed on the fixing plate 35 to cooperate with the steel wire pre-tightening device 254 to stabilize the driving connecting rod 252.

[0104] A wire-driven, single-operated minimally invasive hemostasis medical device. The surgical usage process is as follows: before the surgical operation, the butterfly bolt 126 can be loosened according to the surgical requirements, the position of the front handle base 121 relative to the nasal mirror sleeve 111 can be adjusted, and then the butterfly bolt 126 can be tightened to fix the front handle base 121 and the nasal mirror sleeve 111. During the surgical operation, the doctor first needs to turn on the machine, and press the control button combination 33 to select the surgical mode, adjust the power gear and other parameters, insert the nose mirror 4 into the nose mirror sleeve 111, and then put the plasma knife head 21 and the nose mirror 4 into the human body, find the surgical area through the nose mirror 4, and the doctor fixes the positioning handle 1 with one hand and presses the positioning button 131 with the other hand to push the drive handle 3 to move relative to the positioning handle 1, release the positioning button 131, and then press the direction button 34. The control panel obtains the x-axis and y-axis input signals of the direction button 34, and obtains the motor position through the internal algorithm of the control panel, thereby controlling the yaw and pitch movements of the continuum 22 of the surgical instrument control unit 2. Under the observation of the nose mirror, the plasma knife head 21 is sent to the surgical area, and finally the control button combination 33 is pressed to charge and discharge for surgical operation. At the same time, the suction device 282 is used to suck out the fluid tissue during the operation. After the operation, the control button 33 is pressed to reset the drive unit 25 to zero, adjust the continuum 22 back to the initial state, remove the instrument from the human body, and then shut down to end the operation.

[0105] A control method of a portable minimally invasive hemostasis device for nasal passage is as follows: Fig.22a , as shown in b

[0106] It is known that the relationship between the bending angle θ, curvature k of the continuum, the length l of the central axis of the continuum, and the curvature radius R is:

[0107]

[0108] Get the x of direction button 34 i Axis and y i Axis input data.

[0109] From the geometric relationship in Figure 22, we can get that the end position of the continuum joint x = k x x i and y = k y y i Representation in Cartesian coordinate system:

[0110]

[0111]

[0112] After transformation, we can get:

[0113]

[0114]

[0115] Input the x-axis and y-axis data into the above equations (4) and (5), and use the iterative method to solve the nonlinear equations to calculate θ and φ.

[0116] Depend on Figure 22b The geometric relationship shows that when the rotation angle of the continuum is φ, the curvature radius R of the central axis of the continuum and the curvature radius R of each driving wire are i The relationship is as follows:

[0117] R i =R-rcosα i (6)

[0118] Where r is the distance between the steel wire and the central axis of the continuum;

[0119] Multiply both sides of equation (6) above by θ and assume that l i =R i θ, we can get:

[0120] l i =l-rθcosα i (7)

[0121] l i It represents the length of the i-th driving wire after the continuum is bent at an angle of θ. i represents the change of the i-th driving wire, then l i = l-Δl i The curvature of the continuum is represented by k, so:

[0122] Δl i = rθcosα i (8)

[0123] The drive wire uses a closed-loop drive method, and the following relationship exists:

[0124] Δl 1 =-Δl 3 (9)

[0125] Δl 2 =-Δl 4 (10)

[0126] According to formula (8) and α i The value of can be obtained:

[0127]

[0128]

[0129] Substituting the calculated θ and φ into formula (12), we can calculate Δl 1 and Δl 2 , the diameter of the driving connecting rod is known to be d, then the motor rotation position is:

[0130]

[0131]

Claims

1. A portable minimally invasive hemostasis device for nasal passage, characterized by: The surgical instrument comprises a positioning handle (1), a surgical instrument control unit (2), a driving handle (3), and a nose mirror (4); wherein the positioning handle (1) comprises a limiting device (11), a front handle (12), and a positioning device (13); and the surgical instrument control unit comprises at least a cutting head (21), a continuous body (22), a connecting rod (23), an internal organ (28), and a base (29); The surgical instrument control unit is installed on the front handle of the positioning handle through a connecting rod and is parallel to the limiting device. The connecting rod can move linearly relative to the positioning handle; the driving handle is fixedly connected to the surgical instrument control unit so that the driving handle can move parallel to the positioning handle without deflection; the nose mirror can be inserted into the limiting device of the positioning handle as needed; The continuum of the surgical instrument control unit is installed at the rear end of the connecting rod, the connecting rod is fixedly connected to the base, and the cutter head is installed at the end of the surgical instrument control unit; The continuum and connecting rod are hollow inside, and the internal organs pass through the middle of the continuum and connecting rod to be connected to the base, and further connected to the bedside equipment; The surgical instrument control unit has more than three degrees of freedom, including yaw motion, pitch motion, and forward and backward motion of a follow-up driving handle, so as to position and fix the knife head; wherein the limiting device (11) is composed of a nose mirror sleeve (111) and a spring (112); the front handle (12) is composed of a front handle base (121) and a butterfly bolt (126); the front handle is provided with a first hole (122) for cooperating with the surgical instrument control unit (2) and a second hole (123) for assembling the nose mirror The sleeve (111) has a distance between the first hole and the second hole of less than 1.5 mm; a groove (124) extending from the top plane to the second hole and having a width of less than 1 mm is formed in the middle of the upper end of the front handle base (121); a third hole (127) is further formed on the front handle, and the butterfly bolt is assembled in the third hole; the positioning device (13) is composed of a positioning button (131) and a positioning spring (132), and the positioning device (13) is installed on the base (29); a row of positioning springs (132) is formed on the nose mirror sleeve (111) The positioning hole (114) and the positioning button (131) are designed as hook-shaped structures; a return spring (112) is installed between the base (29) and the front handle base (121), and a limit ring (113) is provided on the nose mirror sleeve (111) to limit the distance of the driving handle (3) moving backward; wherein the continuum (22) is composed of more than two joints; the axes of rotation of adjacent joints are perpendicular to each other; the joints are assembled together by steel wires; each joint can rotate more than 40 degrees on one side relative to the adjacent joint, Therefore, the continuum (22) can be rotated more than 200 degrees in four directions to deliver the blade head (21) to the surgical area; wherein the surgical instrument control unit further comprises a thin tube (24), a drive unit (25), a pulley (26), and a support rod (27); wherein the drive unit (25) is composed of a motor (251), a drive connecting rod (252), a steel wire pre-tightening device (254), and a connecting disc (256), and can drive the continuum (22) to bend more than 200 degrees in four directions; The positioning handle can provide positioning and limiting for the driving handle, so that the driving handle can move forward, backward or rotate around the central axis of the limiting device relative to the positioning handle within a set range.

2. The portable minimally invasive hemostasis device for nasal passage according to claim 1, characterized in that: The viscera (28) include a plasma power cable (281) and a suction device (282), which are installed inside the continuum (22) and the connecting rod (23), and are connected to the bedside device (5) through the rear end interface (291) of the base (29); the continuum (22) is driven by a steel wire, and the steel wire passes through the continuum (22) and the connecting rod (23). When passing through the connecting rod (23), a thin tube (24) with a diameter slightly larger than the diameter of the steel wire is installed, which is used to guide the steel wire inside the connecting rod (23). After passing through the connecting rod (23), the steel wire is connected to the drive unit (25) through a pulley (26), and the pulley (26) is installed on the support rod (27).

3. The portable minimally invasive hemostasis device for nasal passage according to claim 2, characterized in that: The support rod (27) is installed on the base (29) at a certain angle a relative to the line connecting the output shafts of the two drive units (25), so that the steel wire from the capillary (24) is still perpendicular to the central axis of the support rod (27) after passing around the pulley (26), thereby reducing the friction between the steel wire and the pulley 26. The value of a is a=arctan(L / H), L*2 is the distance between the output shafts of the two drive units (25), and H is the distance from the capillary to the line connecting the output shafts of the two drive units 25.

4. The portable minimally invasive hemostasis device for nasal passage according to claim 1, characterized in that: The motor (251) is fixedly connected to the connecting disc (256); the connecting disc is fixedly connected to the driving connecting rod via a bolt (253); and the steel wire pre-tightening device (254) is used to pre-tighten the steel wire.

5. The portable minimally invasive hemostasis device for nasal passage according to claim 4, characterized in that: The wire pre-tightening device (254) is specifically a cylindrical structure, which is divided into an upper cylinder (2541) and a lower cylinder (2542). The end surface of the upper cylinder is provided with a fine groove (25411), the fine groove passes through the center of the circle, the fine groove penetrates to the connecting plane of the upper and lower cylinders on one side of the upper cylinder, and is deep enough to be a distance c from the connecting plane on the other side, so that the upper cylinder has a certain bending elasticity in the direction of the fine groove; the upper cylinder is provided with a thin groove perpendicular to the fine groove. The threaded hole is used to install a pre-tightening bolt (255); the steel wire pre-tightening device is axially perforated and coaxially connected to the output shaft of the driving connecting rod (252); when the pre-tightening bolt (255) is not tightened, the steel wire pre-tightening device (254) can rotate relative to the driving connecting rod (252); the steel wire pre-tightening device (254) and the driving connecting rod (252) are each provided with a steel wire pre-tightening device small hole (25421) and a driving connecting rod small hole (2521) for fixing the steel wire.

6. The portable minimally invasive hemostasis device for nasal passage according to claim 1, characterized in that: One design form of the joint is that the joint is composed of two joint connecting rods (221) nested and connected, the joint connecting rod is a cylindrical structure with two ends open, the outer diameter is less than 5mm, the inner hole diameter is greater than 3mm, and is used to place internal organs (28); four wire holes (223) are evenly distributed inside the outer wall of the joint connecting rod for inserting steel wires, two of which are symmetrical with respect to the central axis and are used to control the pitch movement of the continuum (22), and the other two steel wires are symmetrical with respect to the central axis and are responsible for the deflection movement; the One end opening of the joint connecting rod (221) is provided with two arc grooves (224), and the other end opening is provided with two protruding shafts (222); the axis connecting line of the two arc grooves (224) and the axis connecting line of the two protruding shafts (222) are perpendicular to each other at 90 degrees; the plane cutting angles α on both sides of the arc grooves (224) and the protruding shafts (222) are both greater than 20 degrees; the outer end surfaces of the arc grooves (224) and the protruding shafts (222) are small-angle γ conical surfaces, and the direction of the cone line points to the inside of the joint, thereby ensuring that the two joints are not separated.

7. The portable minimally invasive hemostasis device for nasal passage according to claim 1, characterized in that: Another design form of the joint is that the joint is composed of two half-connecting rods (225) and a connecting component (227), wherein the half-connecting rod is a cylindrical structure with openings at both ends; the outer diameter of the half-connecting rod (225) is less than 5 mm, and the inner hole diameter is greater than 3 mm, and is used to place internal organs (28); four wire holes (228) are evenly distributed inside the outer wall of the half-connecting rod for inserting steel wires, two steel wires symmetrically installed relative to the central axis are used to control the pitch movement of the continuum (22), and the other two steel wires symmetrically installed relative to the central axis are responsible for the deflection movement; one end of the half-connecting rod (225) is opened and provided with two protruding shafts (226), the other end opening is provided with four groups of evenly distributed protrusions (2211) and grooves (2212) for connecting two adjacent half-connecting rods (225), and the protrusion (2211) of one half-connecting rod can be placed in the groove (2212) of the other half-connecting rod; the connecting component (227) is provided with arc grooves (229) on the upper and lower sides, which cooperate with the protruding shaft (226) of the half-connecting rod; the arc groove (229) is provided with a baffle (2210) extending in the opposite direction of the joint axis, which is used to prevent the connecting component (227) from falling; the plane cutting angle β on both sides of the protruding shaft (226) is greater than 20 degrees.

8. A control method for the portable minimally invasive transnasal hemostasis device according to any one of claims 1 to 7, characterized in that: The method includes: Known continuum bending angle , curvature , and the length of the central axis of the continuum , radius of curvature The relationship between them is: (1) Get the direction button (34) Axis and Axis input data; Continuum joint end positions and , and is the geometric scaling factor, expressed in the Cartesian coordinate system: （2） （3） After transformation, we can get: （4） （5） Input the x-axis and y-axis data into the above equations (4) and (5), and use the iterative method to solve the nonlinear equations to calculate: and ; When the rotation angle of the continuum is When the radius of curvature of the central axis of the continuum is The curvature radius of each drive wire The relationship is as follows: （6） Where r is the distance between the steel wire and the central axis of the continuum; ; ; ; ; Multiply both sides of equation (6) above by , and assuming , we can get: （7） Represents the bending of a continuum After the angle, The length of the drive wire; if Indicates The change of the root driving wire is The relationship between the curvature of the continuum and It means that, therefore: （8） The driving wire uses a closed-loop drive method, and the following relationship exists: （9） （10） According to formula (8) and The value of can be obtained: （11） （12） The calculated and Substituting into formula (12), we can calculate and , the diameter of the driving connecting rod is known to be , the motor rotation position is （13） （14）。

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